The field of this invention is fluidic medical diagnostic devices for measuring the concentration of an analyte in or a property of a biological fluid.
A variety of medical diagnostic procedures involve tests on biological fluids, such as blood, urine, or saliva, and are based on a change in a physical characteristic of such a fluid or an element of the fluid, such as blood serum. The characteristic can be an electrical, magnetic, fluidic, or optical property. When an optical property is monitored, these procedures may make use of a transparent or translucent device to contain the biological fluid and a reagent. A change in light absorption of the fluid can be related to an analyte concentration in, or property of, the fluid.
A growing number of assay formats employ a disposable test strip, fluidic device or card which is used in conjunction with a meter. The disposable fluid device receives the sample to be assayed and includes any reagents necessary for the assay to be conducted. The test strip also typically includes one or more flow paths through which the sample flows during the assay.
As mentioned above, these test strips are typically used in conjunction with a meter which is capable of receiving a signal originated in a measurement area of the card. To receive the signal from the measurement area, the test strip is generally inserted into an opening in the meter so that at least the measurement area of the test strip is present inside the meter. Examples of assay systems that are made up of these types of disposable test strips and meters may be found in application Ser. No. 09/333765, filed Jun. 15, 1999; and Ser. No. 09/356248, filed Jul. 16, 1999; the disclosures of which are herein incorporated by reference.
Because the test strip is inserted into the meter in such assay systems, there is necessarily an opening in the meter for receiving the test strip. This opening is potentially a means for interfering materials to enter inside the meter and adversely interact with the internal workings of the meter.
As such, there is a need for the development of a device that is capable of providing entry of a test card or strip into a meter but effectively keeps the inside of the meter free of interfering or contaminating agents.
References of interest include: U.S. Pat. Nos.: 3,620,676; 3,640,267; 4,088,448; 4,426,451; 4,868,129; 5,104,813; 5,230,866; 5,700,695; 5,736,404; 5,208,163; and European Patent Application EP 0 803 288.
Test strip holders for use with test strip meters are provided. The subject test strip holders include at least an opening and a lip associated with the opening. The lip element of the subject holders is capable of forming a liquid seal with the upper surface of a test strip upon insertion of the test strip into the opening. In many embodiments, the strip holder is configured to at least partially encompass a sample application region of a test strip upon insertion of the strip into the opening. Also provided are meters on which the subject test holders are present, as well as methods for using the same.